Therapy device and method of manufacturing the same

ABSTRACT

A foot therapy device for a patient to wear is provided. The foot therapy device includes a sole comprising a front portion, a rear portion, and a middle portion extending there between. A base is coupled to the front portion, the rear portion and the middle portion. A support is coupled to the sole and to the base. The support includes a channel disposed in at least one of the front portion, the middle portion, and the rear portion, wherein the sole and support are configured to apply a proprioception effect to the patient.

BACKGROUND

The disclosure relates generally to a physical therapy device, and more particularly, to a therapy shoe that facilitates proprioception training for physical rehabilitation of a patient, and methods of manufacturing the therapy shoe.

Currently, there is a worldwide emphasis on living healthy lifestyles via various exercise routines. Moreover, a growing percentage of the population requires rehabilitation therapy, physical therapy and/or occupational therapy. For physical therapy purposes, exercise and health care industries emphasize stabilization/stability training. Additionally, fitness professionals and consumers are focusing on core and balance training. Successful core training may require progression, similar to that of endurance or weight training and may require proprioception training principles.

Proprioception relates to a sense of joint position and spatial orientation arising from stimuli from within the body. Proprioception training is an important concept in sport, orthopedic and neurological rehabilitation. An injury to the neuromuscular and or musculoskeletal systems may cause direct or indirect damage to the sensory input and inhibit neuromuscular response. Proprioception training and rehabilitation provide techniques to restore functional mobility and balance, to protect joints, and to improve physical and functional performance.

Studies have shown that proprioception based training protocols improves training/rehab objectives, safety and athleticism. Proprioception rehabilitation and training can be utilized in pre and post orthopedic and sport related injuries such as ankle sprain, stress fractures, ACL injures, total knee and hip replacements. Additionally, proprioception rehabilitation and training can be used for strength and conditioning to improve the athlete's performance and to lower the risk of injuries as an integral part of an injury prevention program. Proprioception training is also commonly used to treat patients post-stroke and patients with various neurological conditions such as Parkinson's disease.

An important aspect of proprioception is balance. In order to improve a person's balance many different training devices are currently available. For balance issues, a current training device is a wobble board, also known as a balance board. This device is a lever design similar to that of a see-saw which the patient stands on, usually with the left and right foot at opposite ends of the board, to facilitate static balance training. Conventional wobble boards may present drawbacks in that it may be dangerous to not only for elderly people who could easily lose their balance, but also to professional athletes due to steepness and speed of the wobble board during use.

Another conventional training device is an inflated silicone dome which offers a bounce surface. To improve balance, an individual stands on the dome portion of the device and attempts to maintain balance. This device, however, may not provide for dynamic movement therapy in both a medical practice as well as a home environment. Also, some patients have expressed a desire to be able to walk around with a training device while performing other activities. Multitasking can lead to not only a more efficient exercise; but also, helps isolate different muscles when compared to performing the exercises individually.

There is a need for a therapy shoe which is configured to actively engage and stimulate the neuromuscular and musculoskeletal systems of the patient. Additionally, there is a need for an individual or health care provider to facilitate sensory input, dynamic balance, core strength and improve the patient's overall lower extremities functional strength. Accordingly, it would be advantageous for a therapy shoe which is configured to provide for proprioception training and dynamic movement therapy in a home setting, medical practice and/or other related settings. Moreover, it would be advantageous for a therapy shoe which is configured to provide dynamic movement therapy while the patient multitasks such as by walking around performing exercise movements.

BRIEF DESCRIPTION

A foot therapy device for a patient to wear is provided. The foot therapy device includes a sole comprising a front portion, a rear portion, and a middle portion extending there between. A base is coupled to the front portion, the rear portion and the middle portion. A support is coupled to the sole and to the base. The support includes a channel disposed in at least one of the front portion, the middle portion, and the rear portion, wherein the sole and support are configured to apply a proprioception effect to the patient.

In another aspect, a therapy shoe is provided. The therapy shoe includes a sole having a front portion, a rear portion, and a middle portion extending there between. A base is coupled to the front portion, the rear portion and the middle portion. A support is coupled to the sole and to the base, wherein the support includes a channel disposed in at least one of the front portion, the middle portion, and the rear portion. A strap is positioned within the channel and removably coupled to the sole, wherein the sole and support are configured to apply a proprioception effect to the patient.

In yet another aspect, a method of manufacturing a therapy device used with a patient's foot is provided. The method includes forming a sole comprising a front portion, a rear portion, and a middle portion extending there between. The method also includes forming a support within the sole, the support comprising a channel disposed in at least one of the front portion, the middle portion, and the rear portion. In the method, a strap is coupled to the channel.

BRIEF DESCRIPTION OF THE DRAWINGS

Features, aspects, and advantages of the present disclosure will become better understood when the following Detailed Description is read with reference to the accompanying drawings in which like characters represent like parts throughout, wherein:

FIG. 1 is a perspective view of an exemplary therapy device;

FIG. 2 is a plan view of the therapy device shown in FIG. 1;

FIG. 3 is a bottom view of the therapy device shown in FIG. 1;

FIG. 4 is a side elevational view of the therapy device shown in FIG. 1;

FIG. 5 is a side perspective view of the therapy device of FIG. 1 showing a patient's foot in a first position with the therapy device;

FIG. 6 is a side perspective view of the therapy device of FIG. 1 showing the patient's foot in a second position with the therapy device;

FIG. 7 is a side perspective view of another exemplary therapy device;

FIG. 8 is a side perspective view of another exemplary therapy device; and

FIG. 9 is a flowchart showing exemplary steps of manufacturing a therapy device.

DETAILED DESCRIPTION OF THE DRAWINGS

The embodiments described herein relate to a therapy device in the form of a therapy shoe. The therapy shoe is directed to training or rehabilitation for patients. The therapy shoe can easily, efficiently, and comfortably engage and stimulate the neuromuscular and musculoskeletal systems of the patient. Moreover, the embodiments relate to a therapy shoe that facilitates sensory input, dynamic balance, core strength, and improving the patient's overall lower extremities functional strength. Additionally, the embodiments relate to a therapy shoe that provides proprioception training and dynamic movement in a variety of settings such as, but not limited to, home, medical, and rehabilitation settings. Further, the embodiments relate therapy shoe which is configured to provide dynamic movement therapy while the patient multitasks such as by walking around performing exercise movements. It should be understood that the descriptions and figures that utilize a sandal as the therapy device are exemplary only. The exemplary therapy device can be used with other rehabilitation devices. Moreover, the embodiments described herein are not limited to a specific size for a patient's foot. The embodiments described incorporate by reference U.S. Provisional Application having Ser. No. 62/065,753 filed on Oct. 19, 2014 entitled “Therapy Shoe”.

FIG. 1 is a perspective view of a therapy device 10 in the form of a shoe or sandal. The therapy shoe 10 includes a sole 12, a base 14, and a support 16. The sole 12 includes a top 18, a bottom 20, a first side wall 22, and a second side wall 24. The first side wall 22 and the second side wall 24 extend between the top 18 and the bottom 20 and each have a sole height H as measured between the top 18 and the bottom 20. In the exemplary embodiment, the height H has a range from about a quarter of an inch to about four inches. Alternatively, height H can be less than a quarter of an inch or more than four inches. The top 18 and the bottom 20 extend between the first side wall 22 and the second side wall 24 and have a sole width W. The width W is variable along a length L of the sole 12. Alternatively, the width W can be uniform along the length L. The width W has a range from about three inches to about ten inches. Alternatively, the width W can be less than three inches or more than ten inches. In the exemplary embodiment, the height H and the width W are selectively sized and shaped to facilitate applying proprioception effects to a patient's foot 26 (shown in FIGS. 5-7) as described herein.

More particularly, the width W is sized to form a predetermined distance 28 around the patient's foot 26. The predetermined distance 28 is measured between at least the first side wall 22, the second side wall 24, and the patient's foot 26. In an embodiment, the predetermined distance 28 is determined by at least considering physical parameters 30 of the patient. The physical parameters 30 include, but are not limited to: sex, height, weight, foot size, physical injury, and neurological conditions such as Parkinson's disease. Alternatively, the predetermined distance 28 can be determined based at least on parameters of an average patient calculated from previous patient parameters. In the exemplary embodiment, the predetermined distance 28 is about half of an inch. Alternatively, the predetermined distance 28 can be less than half of an inch or more than half of an inch. The predetermined distance 28 can be any distance to facilitate applying proprioception effects such as, for example only, stimuli, dynamic movement and balance techniques to the patient as described herein. Additionally, the height H is determined by at least considering the physical parameters 30 of the patient to further facilitate applying proprioception effects to the patient. Along the length L, the sole 12 includes a front portion 32, a rear portion 34, and a middle portion 36. The length L can include a plurality of values to facilitate accommodating for a variety of patient foot lengths. The middle portion 36 extends between the front portion 32 and the rear portion 34. As illustrated, the front portion 32 has a front width 38 which is larger than a rear width 40 of the rear portion 34 and larger than the middle width 42 of the middle portion 36.

For proprioception purposes, the sole 12 includes a synthetic foam 44 such as, but not limited to, microcellular polyurethane foam. Alternatively, the sole 12 can include a synthetic gel. In the exemplary embodiment, the foam 44 has a density distribution 46 that is substantially uniform throughout the sole 12. The density distribution 46 is determined by at least considering the physical parameters 30 of the patient such as: sex, height, weight, foot size, physical injury, and neurological condition such as Parkinson's disease. The density distribution 46 can include a plurality of values. Alternatively, the density distribution 46 can be determined based at least on physical parameters of an average patient calculated from previous patient parameters. The density distribution 46 facilitates applying proprioception effects such as, but not limited to, stimuli, dynamic movement, and balance techniques to the patient as described herein.

Alternatively, the density distribution 46 can be non-uniformly distributed throughout the sole 12. In an alternative embodiment, a portion of the sole 12 can be interchanged with materials of different densities and material compositions. Moreover, in an alternative embodiment, the sole 12 can include a modular configuration in which additional support material can be added or removed to facilitate accommodating the patient's foot 26 depending on specific needs of the patient. In an embodiment, the density distribution 46 is increased in the middle portion 36 as compared to the front portion 32 and/or the rear portion 34. The increased density in the middle portion 36 facilitates providing increased arch support applied to the patient's foot 26 during proprioception training.

FIG. 2 is a top view of the therapy shoe 10. FIG. 3 is a bottom view of the therapy shoe 10. FIG. 4 is a side elevational view of the therapy shoe 10. The base 14 is coupled to the bottom 20 of the sole 12 and along the front portion 32, the rear portion 34, and the middle portion 36. In the exemplary embodiment, the base 14 is integrally formed with the bottom 20. Alternatively, the base 14 can be removably coupled to the bottom 20. The base 14 can include a friction material having non-skid properties to facilitate traction or resistance for the patient walking with the therapy shoe 10.

In the exemplary embodiment, the support 16 is coupled to the sole 12 and the base 14. The support 16 is integrally formed with the sole 12 and the base 14. Alternatively, the support 16 can removably couple to the sole 12 and the base 14. The support 16 includes a channel 48 disposed within at least one of the front portion 32, the rear portion 34, and the middle portion 36. Additionally, the channel 48 is disposed within the bottom 20. In an embodiment, the channel 48 includes a first channel 50 disposed in the front portion 32, a second channel 52 disposed in the middle portion 36, and a third channel 54 disposed in the rear portion 34. As illustrated, the first channel 50, the second channel 52, and the third channel 54 are disposed within the bottom 20. The sole 12 includes a first separator 56 which is positioned between the first channel 50 and the second channel 52. Additionally, the sole 12 includes a second separator positioned 58 between the second channel 52 and the third channel 54. The separators 56, 58 are spaced and configured to selectively position the first channel 50, the second channel 52, and the third channel 54 along the sole 12.

Each of the first channel 50, the second channel 52, and the third channel 54 include a first side 60, a second side 62, and a base 64 extending there between. The first side 60 and the second side 62 extend from the first side wall 22 and the second side wall 24 and into the sole 12. The first side 60 and the second side 62 are positioned in the base 14 within the sole 12 and offset or recessed from the first side wall 22 and the second side wall 24. Since the base 14 is offset from the first side wall 22 and the second side wall 24, each of the first channel 50, the second channel 52, and the third channel 54 has a channel width which is less than the sole width W. Additionally, the first side 60 and the second side 62 extend from the bottom 20 and into the sole 12. The first side 60 and the second side 62 are positioned in the base 14 within the sole 12 and offset or recessed from the bottom 20. As illustrated in FIG. 2, the top 18 is substantially planar or flat along the first portion 32, the second portion 34, and the third portion 36. The flat top 18 is configured to facilitate applying proprioception effects to the foot 26 as described herein.

FIG. 5 is a side perspective view of the therapy shoe 10 showing the patient's foot 26 in a first position 66. FIG. 6 is a side elevational view of the therapy shoe 10 showing the patient's foot 26 in a second position 68. In the exemplary embodiment, the support 16 includes a strap 70 positioned within the channel 48 and removably coupled to the sole 12. The strap 70 includes a foot strap 72 coupled to at least one of the front portion 32 and the middle portion 36. In an embodiment, the foot strap 72 is removably coupled to at least one of the front portion 32 and middle portion 36. More particularly, the foot strap 72 is coupled to at least one of the first channel 50 and the second channel 52. The strap 70 includes an ankle strap 74 coupled to the rear portion 34. In an embodiment, the strap 70 is removably coupled to the rear portion 34. More particularly, the strap 70 includes an ankle strap 74 coupled to the third channel 54. The strap 70 is sized and shaped to contact at least one of the first side 60, the second side 62, and the base 64 of each of the first channel 50, the second channel 52, and the third channel 54. More particularly, the foot strap 72 is configured to selectively fit within at least one of the first channel 50 and the second channel 52. The ankle strap 74 is configured to fit within the third channel 54. Since the base 64 of each of the first channel 50, second channel 52, and the third channel 54 extend from the first side wall 22, the second side wall 24, and the bottom 20 and into the sole 12, the front strap 70 and the ankle strap 74 do not extend beyond the first side wall 22, the second side wall 24, and the bottom 20.

The straps 72 and 74 can be secured to the channels 50, 52, and 54 by a fastener (not shown) such as, but not limited to, adhesives, clasps, and buttons. The straps 72, 74 can include an expansion material such as elastic to facilitate stretching to accommodate the patient's foot 26. The strap 74 may also include a loop (not shown) in which the patient inserts the foot 26 through the loop and the ankle is secured thorough elastic properties of the trap 74. Moreover, the straps 72, 74 may include a fastener, for example a hook and loop fastener to comfortably and efficiently secure the foot 26 to the sole 12. The foot strap 72 is selectively coupled to at least one of the first channel 50 and the second channel 52 to facilitate accommodating for different sizes of the patient's foot 26. For example, for a smaller foot size, the first strap is removably coupled to the second channel 52 in the first position 66. For a large foot size, the foot strap 72 is removably coupled to the first channel 50 in the second position 68.

During an exemplary use of the therapy shoe 10, the physical parameters 30 of the patient are considered. The therapy shoe 10 is designed and/or chosen based at least on the physical parameters 30. The flat top 18 of the therapy shoe 10 is placed on the patient's foot 26. Based at least on the size of the foot 26, the channel 48 of the support 16 is chosen. The foot strap 72 is removably coupled to and placed within the first channel 50. For a shorter sized foot 26, the foot strap 72 is removably coupled to and placed within the second channel 52 in the first position 66. For a large foot 26, the foot strap 72 is removably coupled to and placed within the first channel 50 in the second position 68. When the foot strap 72 is selectively coupled to at least one of the first channel 50 and the second channel 52, the ankle strap 74 is removably coupled to the third channel 54. The foot strap and the ankle strap 74 are selectively tightened to comfortably and efficiently secure the foot 26 to the sole 12, and in particular to the top 18.

The patient walks around and/or performs proprioception exercises while wearing the therapy shoes 10 on both feet 26. The density distribution 46 of the foam 44 applies sensory input and stimuli to the patient's foot 26 which facilitates stimulation of the neuromuscular and musculoskeletal systems of the patient. Additionally, the predetermined distance of the sole 12 around the foot 26 applied an unbalanced effect to the patient which facilitates the patient counterbalancing during walking or exercise routines. By counterbalancing the uneven effect of the predetermined distance, the patient improves dynamic movement and balance to improve neuromuscular and musculoskeletal systems of the patient. Further, the flat top 18 of the sole 12 applies an unbalanced effect to the patient. Additionally, the height H of the sole 12 applies can apply an unbalanced effect to the patient. By counterbalancing, the patient improves dynamic movement and balance to improve neuromuscular and musculoskeletal systems of the patient.

During proprioception training or rehabilitation, the therapy shoe 10 improves the patient's core strength and the functional strength of the patient's lower extremities. Since the therapy shoe 10 can easily and efficiently be used, the patient can use the therapy shoe 10 in home setting or medical facility. Additionally, the patient can use the therapy shoe 10 while multitasking such as walking around and performing proprioception exercises. The therapy shoe 10 can be color coded to illustrate different density distributions 46 to indicate shoes for specific patients such as new patients or patient with Parkinson's disease. During proprioception training, the patient can use initially use a more dense foam 44. The patient can graduate or escalate and use less dense foam 44 wherein the lesser density provides more unbalanced or unstable effects to the patient to increase the effects of the proprioception training.

FIG. 7 is a side perspective view of another therapy shoe 76. In FIG. 7, the same components as shown in FIGS. 1-6 include the same element numbers as shown in FIGS. 1-6. In the exemplary embodiment, the channel 48 includes the front channel 50 and the rear channel 54. The first channel 50 and the rear channel 54 are specifically sized for a particular size of the patient's foot 26. The length of the therapy shoe 76 can include a large size and a small size to facilitate accommodating for different patient foot sizes. The length of the therapy shoe 76 can also include a medium size.

FIG. 8 is a side perspective view of another therapy shoe 78. In FIG. 8, the same components as shown in FIGS. 1-6 include the same element numbers as shown in FIGS. 1-6. In the exemplary embodiment, the channel 48 includes a hollow configuration which is disposed through the sole 12. In an embodiment, the channel 48 is embedded within and surrounded by the sole 12. Additionally, a heel of the rear portion 34 can extend vertically from the sole 12 and is configured to partially surround the patient's heel when the patient wears the therapy shoe 78. Moreover, a toe portion of the front portion 32 can extend vertically from the sole 12 and is configured to partially surround the patient's toe(s) when the patient wears the therapy shoe 78. The elevated portions are configured to present a place in which the patient fits or nests the foot 26 to facilitate securing the foot 26 to the sole 12. The length of the therapy shoe 76 can include a large size and a small size to facilitate accommodating for different patient foot sizes. The length of the therapy shoe 76 can also include a medium size.

FIG. 9 is a flowchart illustrating steps of manufacturing the therapy shoe 10. The method 900 includes forming 902 the sole 12 having the front portion 32, the rear portion 34, and the middle portion 36. In the method 900, the sole 12 can be formed from microcellular polyurethane foam 44. The sole 12 is formed 904 having a predetermined width and density distribution. In the exemplary method 900, the support 16 is formed 906 within the sole 12. The support 16 includes forming the channel 48 disposed within at least one of the front portion 32, the rear portion 34, and the middle portion 36. In the exemplary method 900, the channel 48 can be formed into the first channel 50, the second channel 53, and the third channel 54. The method 900 further includes coupling the strap 70 to the channel 48.

The embodiments described herein relate to a dynamic balanced shoe that is configured to actively engage and stimulate the neuromuscular and musculoskeletal systems of the patient while facilitating sensory input, dynamic balance and core strength of the patient's lower extremities. The foot bed is made of microcellular polyurethane foam and has removable adjustable straps that hold onto the foot at the ankle and at the midfoot. In the exemplary embodiments, the bottom of the foot bed has three channels, one at the ankle level, which the patient secures the base of their foot, and two additional channels at the midfoot level. Depending on the foot size one would use the closer or farther channel to put the strap on. The foot should have extra space around the whole foot in order to have the “unstable” feeling required to stimulate and engage the core muscles for stability and proprioception training.

In the embodiments described, the therapy shoe can be available in two color-coded density levels that provide a progressive system of balance training. Patients/clients can improve balance and proprioceptive skills by progressing through the two levels with differing density distributions. Because of its compact size, the therapy shoe is ideal for clinic/hospital or a send-home therapy tool. Advantages of the dynamic balance therapy shoe are: dynamic; compact size; safe, convenient, and efficient to use to facilitate patient compliance during proprioception training. The term “patient” can include a person with a physical injury and/or neurological condition. Additionally, the term “patient” can include athletes or other persons in training. The term “patient” can include any person performing exercise, training, and/or rehabilitation routines.

When introducing elements of the present invention or the preferred embodiment(s) thereof, the articles “a”, “an”, “the” and “said” are intended to mean that there are one or more of the elements. The terms “comprising”, “including” and “having” are intended to be inclusive and mean that there may be additional elements other than the listed elements.

Exemplary embodiments of a therapy device are described herein. The methods and assemblies are not limited to the specific embodiments described herein, but rather, components of assemblies and/or steps of the methods may be utilized independently and separately from other components and/or steps described herein. For example, the methods may also be used in combination with other assemblies and methods, and are not limited to practice with only the assemblies and methods described herein. Rather, the exemplary embodiments may be implemented and utilized in connection with any other therapy equipment.

Although specific features of various embodiments of the invention may be shown in some drawings and not in others, this is for convenience only. In accordance with the principles of the invention, any feature of a drawing may be referenced and/or claimed in combination with any feature of any other drawing.

This written description uses examples to disclose the invention, including the best mode, and also to enable any person skilled in the art to practice the invention, including making and using devices or assemblies or systems and performing any incorporated method. The patentable scope of the invention is defined by the claims, and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they have structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements with insubstantial differences from the literal languages of the claims. 

What is claimed is:
 1. A foot therapy device for a patient to wear, the foot therapy device comprising: a sole comprising a front portion, a rear portion, and a middle portion extending there between; a base coupled to the front portion, the rear portion and the middle portion; and a support coupled to the sole and to the base, the support comprising a channel disposed in at least one of the front portion, the middle portion, and the rear portion, wherein the sole and support are configured to apply a proprioception effect to the patient.
 2. The foot therapy device of claim 1, wherein the sole comprises microcellular polyurethane foam.
 3. The foot therapy device of claim 1, wherein the sole comprises a synthetic foam having a substantially uniform density distribution throughout the sole.
 4. The foot therapy device of claim 1, wherein the sole comprises a synthetic foam having a non-uniform density distribution throughout the sole.
 5. The foot therapy device of claim 1, wherein the sole comprises a first side wall, a second side wall, and sole width extending there between, the sole width comprising a range from about three inches to about ten inches.
 6. The foot therapy device of claim 5, wherein the channel comprises a channel width which is less than the sole width.
 7. The foot therapy device of claim 1, wherein the channel comprises a first channel disposed in the front portion, a second channel disposed within the middle portion, and a third channel disposed in the rear portion.
 8. The foot therapy device of claim 1, wherein the channel comprises a first channel disposed in the front portion, a second channel disposed within the middle portion, and a separator between the first channel and the second channel.
 9. The foot therapy device of claim 1, wherein the front portion has a front width, the middle portion has a middle width, and the rear portion has a rear width, the front width is larger than the middle width and the rear width.
 10. The foot therapy device of claim 1, wherein the support comprises a strap positioned within the channel and removably coupled to the sole.
 11. A therapy shoe comprising: a sole comprising a front portion, a rear portion, and a middle portion extending there between; a base coupled to the front portion, the rear portion and the middle portion; a support coupled to the sole and to the base, the support comprising a channel disposed in at least one of the front portion, the middle portion, and the rear portion; and a strap positioned within the channel and removably coupled to the sole, wherein the sole and support are configured to apply a proprioception effect to the patient.
 12. The therapy shoe of claim 11, wherein the strap comprises a foot strap coupled to at least one of the front portion and the middle portion.
 13. The therapy shoe of claim 11, wherein the strap comprises an ankle strap coupled to the rear portion.
 14. The therapy shoe of claim 11, wherein the sole has a top, a bottom, and a height extending there between, the height having a range from about a quarter of an inch to about three inches.
 15. The therapy shoe of claim 11, wherein the sole comprises a substantially flat top.
 16. The therapy shoe of claim 1, wherein the sole has a top and a bottom and the channel is disposed in the bottom.
 17. The therapy shoe of claim 1, wherein the sole has a top and a bottom, the channel comprises a first channel, a second channel, and a third channel which are disposed within the bottom.
 18. The therapy shoe of claim 1, wherein the sole has a substantially flat top and a substantially flat bottom.
 19. A method of manufacturing a therapy device used with a patient's foot, the method comprising: forming a sole comprising a front portion, a rear portion, and a middle portion extending there between; forming a support within the sole, the support comprising a channel disposed in at least one of the front portion, the middle portion, and the rear portion; and coupling a strap to the channel.
 20. The method of claim 19, wherein forming the sole comprises forming the sole having a predetermined distance around the patient's foot. 